Regulatory approval

Published by the Health Canada. Approved

Health Canada approved ribociclib, in combination with fulvestrant, for the treatment ostmenopausal women, with HR-positive, HER2-negative advanced or metastatic breast cancer, as initial endocrine-based therapy or following disease progression on endocrine therapy.

This is written in the approval document as:

KISQALI (ribociclib tablets) is indicated, in combination with fulvestrant for the treatment of postmenopausal women, with HR-positive, HER2-negative advanced or metastatic breast cancer, as initial endocrine-based therapy or following disease progression on endocrine therapy.

Citation

Novartis Pharmaceuticals Canada Inc. Kisqali (ribociclib) [product monograph]. Health Canada website. https://pdf.hres.ca/dpd_pm/00083872.PDF. Revised March 2026. Accessed April 2026.

Therapeutic response

Precision oncology relationships for therapeutic response derived from this regulatory approval.

Organizations	Biomarkers	Cancer types	Therapies
HC (1)	ER positive, HER2-negative	Invasive Breast Carcinoma	Fulvestrant, Ribociclib
HC (1)	HER2-negative, PR positive	Invasive Breast Carcinoma	Fulvestrant, Ribociclib
HC (1)	ER positive, HER2-negative, PR positive	Invasive Breast Carcinoma	Fulvestrant, Ribociclib

Contributions

Date	Contributor	Description
2024-10-30	Van Allen lab	Initial access of FDA approvals